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FDA Warning Regarding Gadolinium-Based Contrast Agents

doctor look at a catscan

The FDA recently announced additional warnings for Gadolinium-based contrast agents which are commonly used during MRI procedures. The warning states:

"The FDA reviewed available data about the retention of gadolinium from gadolinium-based contrast agents as part of its role in monitoring the post-market safety of drugs. As a result of that review, we recommend that health care professionals consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition. We are requiring a class-wide warning about gadolinium retention in the labeling of GBCAs and a new medication guide that should be presented to patients in advance of receiving a GBCA," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "The FDA will continue to assess the safety of GBCAs, and to that end, we are requiring GBCA manufacturers to conduct further studies to assess the safety of this class of contrast agents."

The warning is based on claims that gadolinium may be retained in bones or organs longer than drug manufacturers had ensured.


Radiologists use Gadolinium in approximately 1 of 3 MRI scans after evaluating the patient’s known health history. Generally, it is not recommended for patients who have severe kidney disease or who have a known allergy. Gadolinium is a metal-based chemical substance which is injected intravenously during an MRI to enhance the images and thus improve accuracy of the scan.


Build-up of gadolinium can potentially have severe health consequences. Possible health problems include:

  • Skin changes – darkening and thickening of the skin, itchiness
  • Shortening of the muscles and tendons
  • Bone pain
  • Vision issues
  • Problems with swallowing
  • Hair loss

Patients who have multiple exposures to gadolinium dyes during MRIs have higher risks of gadolinium retention in their bodies. Additionally, patients with a kidney condition are particularly susceptible to these possible side-effects and can end up developing a serious condition called Nephrogenic Systemic Fibrosis (NSF). NSF begins with a hardening of the skin and muscles and can result in limitations in or complete restriction of mobility.


There are allegations against Pharmaceutical companies were aware of the increased risks of gadolinium dyes before the FDA issued its warning. If you or someone you know has had serious health problems that you believe arose from MRI exposures to gadolinium, you should consider contacting a Kentucky attorney to evaluate your potential case. Please contact Brett H. Oppenheimer, PLLC, to consult with you free of charge and help you determine your best course of action.

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